Kornimate/medical-research-clean huggingface dataset:
eplerenone treatment for chronic central serous chorioretinopathy in hungarian population

Conditions: Chronic Central Serous Chorioretinopathy

Summary: the aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.


Eligibility criteria:
inclusion criteria: * chronic central serous chorioretinopathy (cscr) with persistent subretinal fluid on oct for more than 3 months after initial presentation . * written informed consent exclusion criteria: * persons with impaired decision-making ability. * pregnant women or who are actively trying to conceive. * additional eye disease affecting the macula or posterior retina. * creatinine clearance \< 50 ml/min * hyperkalemia \> 5 mmol/l * serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women * treatment with potassium sparing agents or potassium * treatment with any other drugs known to cause interaction with eplerenone * microalbuminuria in patients with type 2 diabetes
contingency management as an adjunct treatment for rural and remote disordered gamblers

Conditions: Gambling Disorder

Summary: the purpose of this project is to pilot contingency management as an adjunct treatment to counselling as usual using internet delivered video-conferencing applications for remote disordered gamblers. this project further investigates the impact of adding contingency management to counselling to improve counselling attendance and retention and uses internet-delivered approaches to assist rural and remote disordered gamblers gain access to counselling treatments.

the chosen methodology is a randomised clinical trial where participants are allocated into one of two conditions; contingency management and cognitive behavioural therapy (cm+), or cognitive behavioural therapy alone (cbt) for the treatment of disordered gambling. participants will experience a battery of tests pre- and post-treatment examining clinical, psychological, and behavioural issues, including co-morbid substance use. alberta rural development network (ardn) affiliates will be provided with information regarding how participants can access the qualtrics study site (e.g., an on-line survey hosting company) and will be individually directed to the study site by the principal investigator to complete the consent form and the base-line assessments. counselling will be provided free of charge using skype or facetime video-conferencing internet applications. participation in each condition will last 14 weeks: 12 weeks for treatment, and 2 weeks of assessments (one week prior to treatment and one week post treatment). pre-treatment assessments (including demographic information) will take approximately 30-45 minutes, as will the post-treatment assessments. the progress check-ups by the principal investigator will take 5 to 10 minutes. a subset of treatment seekers, counsellors, and community/project stakeholders (e.g., ardn affiliates) will also be chosen to participate in qualitative interviews to explore their experiences as well as their perceptions regarding the utility of the program for residents of rural and remote areas. the qualitative interviews will take approximately 30-60 minutes.

Eligibility criteria:
inclusion criteria: * capable of providing written consent, * received a diagnosis of gambling disorder (american psychiatric association, 2013), * gambled within the last month, * live in a rural or remote location, and * speak english exclusion criteria: * medically unmanaged psychiatric or neurological disorder(s) except for disordered gambling

Keywords: internet contingency management gambling disorder rural
web-based guided self-determination intervention for adults with type 2 diabetes in general practice

Conditions: Type 2 Diabetes

Summary: the overall aim of this study is to assess the effectiveness of a web-based guided self-determination program among adults with type 2 diabetes in general practice in order to improve diabetes self-management behaviours and hba1c through enhanced patient activation, self-care competence, and autonomy.

web-based self-management programs have the potential to support adults with type 2 diabetes in managing their disease condition. however, improving health care outcomes through self-management interventions have shown somewhat ambiguous results. therefore, it is suggested that interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. to meet these challenges, the overall aim of this study is to assess the effectiveness of a theory-driven web-based guided self-determination intervention among adults with type 2 diabetes in general practice in order to enable adults with diabetes to use their individual resources to self-manage their condition and reach treatment goals. a complex intervention design based on the framework of uk medical research council is employed as a guide for developing and evaluating the intervention. this study consists of three phases: 1. the modelling phase adapting the original guided self-determination program to adults with type 2 diabetes, using a qualitative design 2. feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and 3. evaluating the effectiveness of the intervention on diabetes self-management behaviours and hba1c, using a quasi-experimental design. the two first phases will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effect on health care outcomes of this systematically developed intervention.

Eligibility criteria:
inclusion criteria: * type 2 diabetes of duration ≥ 3 months * ability to communicate in norwegian * access to the internet and bank id exclusion criteria: * patients with cognitive impairment * patients with severe co-morbidity

Keywords: self-management web-based quantitative approach
the effect of ultrasound-guided erector spinae block on respiratory function after laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy; Postoperative Pain; Respiratory Function

Summary: the aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: • american society of anesthesiology (asa) physical status i-ii patients who were scheduled for elective laparoscopic cholecystectomy exclusion criteria: * patients refusal * contraindications for regional anesthesia * alcohol or drug abuse * chronic opioid intake * patient with psychiatric disorders * use of pain killers within the 24 h before the operation * respiratory tract infection within the last 2 weeks * smoker or history of smoking * allergy to local anesthetics * respiratory and allergic diseases * cardiac disease associated with dyspnea

Keywords: erector spinae block laparoscopy respiratory function
in-person versus online debriefing in hbb

Conditions: Neonatal Respiratory Distress

Summary: the objective of this study is to assess the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the hbb course in comparison to traditional face-to-face feedback. the working hypothesis is that online feedback and debriefing during hands-on training sessions are as effective as face-to-face feedback and debriefing in teaching clinical skills to medical and nursing students.

online learning has become an integral part of education, especially during the ongoing covid19 pandemic that has imposed a limit on live interactions. this observation holds true in the medical education system which uses the flipped classroom model to teach essential practical skills. studies have shown that this model is associated with improved learning and student satisfaction. in such a model, debriefing and feedback comprise a main part of the teaching process, and these interactions are usually conducted in person. one helpful skill offered to nursing and medical students is helping babies breathe (hbb), which is an evidence-based educational program training first-line birth attendants to initiate effective resuscitation of a newborn in the first minute of life. the investigators propose to incorporate online feedback as part of the hbb course at the american university of beirut. in this non-inferiority randomized controlled trial, the investigators will study the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the hbb course in comparison to traditional face-to-face feedback. the working hypothesis is that internet-based live feedback and debriefing are as effective as face-to-face interactions when teaching clinical skills to nursing and medical students. this work will aid in developing a reliable online curriculum that can be extrapolated to other courses and institutions, thus broadening the reach of medical education in the times of physical distancing.

Eligibility criteria:
inclusion criteria: * nurses and medical students exclusion criteria: * attended resuscitation course

Keywords: online debriefing in person debriefing helping babies breathe debriefing simulation training
emotional burden of healthcare professionals and covid infection 19

Conditions: Emotionnal Distress; COVID-19

Summary: covid-19 ( known as severe acute respiratory syndrome coronavirus 2 (sars-cov-2)) has a highly polymorphic clinical presentation, ranging from pauci-symptomatic infection to severe, potentially complicated forms with acute respiratory distress syndrome or multisystemic organs failure. the picture may be initially severe, or it may progress in two stages, with worsening 7 to 10 days after the first symptoms with an overall case-fatality rate of 3 to 4%. its management is essentially symptomatic, as no antiviral treatment has so far demonstrated a clinical benefit in this condition. in such a context, healthcare professionals assigned to covid units will be faced with a heavy workload and emotional burden that could lead to psychological suffering or even burnout and its consequences. we would therefore like to describe, using validated tools, the emotional evolution of the care workers at the limoges university hospital and the esquirol university hospital faced with this new pandemic infection. an initial and end-of-study evaluation of the caregivers will be carried out concerning their anxiety and depressive state, their personal capacity for resilience and their degree of empathy


Eligibility criteria:
inclusion criteria: * health professional working in a covid unit * for the qualitative study: 24 participant selected at random to be interviewed exclusion criteria: * refusal to participate
a phase ib/ii study to investigate the safety of shr-1819 in children and adolescents with moderate-to-severe atopic dermatitis

Conditions: Children and Adolescents With Moderate-to-severe Atopic Dermatitis

Summary: this trial was designed to evaluate the safety of shr-1819 in children and adolescents with moderate-to-severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: 1. subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study; 2. at the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female; 3. have atopic dermatitis at screening. exclusion criteria: 1. before enrollment, the subjects weighed \< 15kg; 2. females who are pregnant or lactating and have a positive pregnancy test result; 3. have other active skin disease or skin complications due to other conditions that may affect the evaluation of ad; 4. have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial; 5. treated with biologics targeting il-4rα , or participated in previous clinical studies of biologics targeting il-4rα, including shr-1819 injection; 6. has malignancy or has a history of malignancy; 7. hypersensitivity to the study drug or any ingredient in the study drug.
a study of ly3532226 in participants with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug ly3532226 in participants with type 1 diabetes mellitus (t1dm). the study will also evaluate if ly3532226 helped participants to recover from insulin-induced low blood sugar condition compared to placebo. the study will last approximately 16 weeks excluding screening period.


Eligibility criteria:
inclusion criteria: * participants with type 1 diabetes mellitus (t1dm) for at least 2 years treated with insulin * body mass index (bmi) of 18.5 to 40.0 kilograms per meter squared (kg/m²) * are males or females not of childbearing potential exclusion criteria: * have acute proliferative retinopathy requiring active treatment within 3 months of screening * have been treated with dipeptidyl peptidase-ni, glp-1 receptor agonists, gip agonists, metformin or sodium-glucose cotransporter 2 inhibitors within the previous 3 months * have received systemic or inhaled glucocorticoid therapy * women of childbearing potential * are currently taking part in another clinical study trial involving medical research, or have participated within the last 30 days of screening in a clinical study involving a study intervention
bhaktapur maternal and child micronutrient study

Conditions: Malnutrition, Infant; Malnutrition; Anemia

Summary: between february 2008 and february 2009, 500 infant-mother pairs in bhaktapur, nepal were randomly selected in this nutritional survey. the dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.the objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. these mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. the objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. the women attended a hospital for physical examination, dietary interview, and blood sampling. blood samples were also collected from their infants who also went through a detailed clinical examination the blood samples from mothers and infant pairs were collected approximately one week apart. the blood was spun down, plasma separated and transferred into storage vials immediately. plasma and blood pellets were stored in cryovials at -70 until analysis. all women were also requested to provide one breast milk and one urine sample. plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis. plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin a, vitamin d, vitamin e, several amino acids and other micronutrient related metabolites. the breast milk will be analyzed for iodine, fatty acids, and several b vitamins the urine was analyzed for iodine. in phase 2, after 5 years we revisited the mother-child pairs and measured growth, diet, food security, and neurodevelopment.

Eligibility criteria:
inclusion criteria: * availability of consent * no ongoing illness * resides in the selected cluster * that household information could be obtained * that the mother was lactating exclusion criteria: * refused blood sampling * chronic illness

Keywords: nepal breastfeeding micronutrients women infants
acupuncture for pain relief during induced labour in nulliparae

Conditions: Pain

Summary: the study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. the other outcomes of labour were to be observed in addition.

the study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. the study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.

Eligibility criteria:
inclusion criteria: * nulliparae * having labour induced for prolonged pregnancy or mild hypertension * no previous experience of acupuncture * give written informed consent exclusion criteria: * all who do not meet the inclusion criteria

Keywords: acupuncture induced labour labour outcome nulliparae pain-relief epidural during labour
safety and pharmacokinetic study of intravenous ibuprofen in pediatric patients

Conditions: Pain; Fever

Summary: the primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

the primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Eligibility criteria:
inclusion criteria: * be a hospitalized male or female subject between birth (\> 37 weeks gestational age) and \< six (6) months of age. * have a clinical indication of pain or fever. * have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures. exclusion criteria: * have inadequate intravenous access. * have an uncorrected ductus dependent congenital heart disease. * have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin. * have a current history of uncorrected hypovolemia or acute renal disease. * have a current history of acute liver disease. * have received nsaid, acetaminophen, or aspirin drug therapy within four hours prior to dosing. have received another investigational drug within the past 30 days. * be otherwise unsuitable for the study, in the opinion of the investigator.

Keywords: pediatric (birth to less than 6 months of age) pain fever
safety and efficacy of prometrium® capsules in induction of secretory conversion

Conditions: Secondary Amenorrhea

Summary: to evaluate the efficacy and safety of 300 mg and 400 mg doses of prometrium® capsules in women of reproductive age with secondary amenorrhea


Eligibility criteria:
inclusion criteria: * women with secondary amenorrhea * normal serum dehydroepiandrosterone (dhea), prolactin, testosterone, thyroid stimulating hormone (tsh) and thyroxine exclusion criteria: * primary amenorrhea * other medical conditions resulting in amenorrhea (e.g. asherman's syndrome) * peanut allergy * allergy to progestational steroids

Keywords: to collect additional data on 300 and 400 mg doses of prometrium in women with secondary amenorrhea
instrumented thoracic and lumbar arthrodesis supplemented by the implanet jazz systemtmd

Conditions: Spondylolisthesis; Spinal Stenosis; Proximal Joint Kyphosis (PJK)

Summary: establish a data repository of patients who have undergone thoracic and/or lumbar instrumented arthrodesis procedure supplemented by the implanet jazz system.

the purpose of this study is to create a data repository of patients who have undergone spinal arthrodesis procedures supplemented with the implanet jazz system. this device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from t1 to l5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion. patients who are candidates for hybrid thoracolumbar fixation with the implanet jazz system during arthrodesis surgery will be asked to participate in this protocol. clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36 48, and 60 months post surgery in the database. data collected will include demographic and surgical information, physiological data, neurological assessments and patient reported outcomes. this comprehensive database will allow for gathering of relevant information for potential future research use.

Eligibility criteria:
inclusion criteria: * patients who are candidates for spinal arthrodesis surgery (thoracic and/or lumbar) supplemented by the implanet jazz system are eligible to participate in this study. exclusion criteria: * patients under the age of 18 are excluded because the investigators do not routinely perform spinal arthrodesis surgery on these patients.
ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary: heart failure with preserved ejection fraction (hfpef) is a large medical problem, for which no drug or device has a recommendation in current heart failure guidelines. sudden cardiac death is suggested as the most common cause of death in hfpef patients, although data is sparse. use of an implantable loop recorder (ilr) may be useful in patients with hfpef to evaluate the incidence of sustained ventricular tachyarrhythmias. if ventricular tachyarrhythmias are seem frequently, treatment with an implantable cardioverter defibrillator (icd) may be an option in the future.


Eligibility criteria:
inclusion criteria: clinical criteria: 1. age \>18 years 2. written informed consent 3. hf with moderate to severe symptoms nyha ii or iii 4. hospitalization or emergency room visit for hf or symptom relief with diuretics within 12 months 5. sinus rhythm or af echocardiographic criteria: 1. lvef \>40% 2. left atrial size (volume ≥34 ml/m2 or la parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or lv diastolic dysfunction (e/e' ≥13 or mean e' septal and lateral wall \<9 cm/s). biomarker criteria: 1. bnp \>100ng/l or nt-pro-bnp\>400ng/l if sinus rhythm 2. bnp \>300ng/l or nt-pro-bnp\>1200ng/l if atrial fibrillation exclusion criteria: 1. patients unwilling or unable to sign informed consent 2. patients with a pacemaker or icd 3. indication for icd therapy according to the esc guidelines 4. life expectancy of less than one year 5. significant coronary artery disease or myocardial infarction \< 3 months 6. complex congenital heart disease 7. pregnancy

Keywords: heart failure with preserved ejection fraction (hfpef) ilr ventricular tachyarrhythmias safety